Simplification of certain requirements and procedures for chemical products (Omnibus VI)

The European Parliament adopted by 540 votes to 60, with 45 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products.

The matter was referred back for interinstitutional negotiations to the committees responsible.

This proposal is part of the sixth simplification omnibus to reduce compliance costs and administrative burden for the chemical industry while ensuring strong protection of human health and the environment.

The proposed amendments concern the following acts:

Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

- the term ‘digital contact’ is clarified to mean any up-to-date easily and freely accessible online communication channel such as email addresses or a weblink through which a supplier can be contacted without the need to register or to download or use an application. In order to ensure the possibility for rapid contact which is essential in certain situation such as in cases of emergency, the presence of a digital contact should not exclude the provision of a telephone number;

- by 18 months from the date of the entering into force of this Amending Regulation, the Commission will carry out an assessment on whether further specific reductions of mandatory label elements should apply to packages between 10 and 125 ml;

- the label elements may be reduced where: (a) the content of the packaging of a substance or a mixture does not exceed the required quantities; and (b) the packaging is either in such a shape or form or is too small in size to allow for a full reference to all the elements referred to in Article 31 in all the languages of the Member State in which the substance or mixture is placed on the market;

- suppliers should be allowed to reduce hazard information on the label of ink cartridges intended for use in a printer, under certain conditions;

- in the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label, the supplier of that substance or that mixture will ensure that the label is updated without undue delay and in any event no later than eighteen months after the results of the new evaluation are obtained by, or communicated to, that supplier;

- any advertisement to the general public for a substance or a mixture classified as hazardous must always include the sentence: ‘Always read the label and product information before use.’, and also include one of the following: a) the applicable hazard pictogram(s); or b) the relevant signal word.

Regulation (EC) No 1223/2009 on cosmetic products

Substances classified as CMR category 1A or 1B may be used in cosmetic products exceptionally if a derogation request is submitted to the Commission and the Commission grants the derogation from the general prohibition laid down in the regulation. The Commission may grant the derogation where the substances have been evaluated and found safe by the SCCS for one or more particular uses of one or more cosmetic product categories considering overall exposure from the uses in those products categories as well as from sources other than cosmetics and of vulnerable population groups.

A substance will be considered an appropriate alternative if: (i) its use in cosmetic products is safe and results in reduction of overall risk to human health, when assessed against the substance it is intended to replace; (ii) it provides an equivalent function to the classified substance, in a finished cosmetic product with a comparable effect, level of efficacy and performance; (iii) is technically feasible and economically feasible provided costs and supply conditions allow sustained production; (iv) it is not restricted and is either available on the market at scale and in quantities sufficient to meet current demand or has the potential to meet current or expected demand in a reasonable timeframe.

Cosmetic products containing prohibited or non-compliant carcinogenic, mutagenic and reprotoxic substances may remain temporarily on the market following a regulatory change, with the timeframe varying depending on the situation:

- if no derogation request was submitted: a period of 6 months for placing and 15 months for making available on the market;

- request for derogation if the substance is not safe: 3 months for placing and 12 months for making available on the market;

- request for derogation if the substance is safe, but the request has been refused due to the availability of suitable alternatives: 24 months for placing and 48 months for making available on the market, under the condition that an up-to-date product safety report remains available at all times.

Cosmetic products containing nanomaterials will be notified to the Commission by the responsible person by electronic means prior to being placed on the market. The information notified to the Commission will contain at least the identification of the nanomaterial and the specification of the nanomaterial including size of particles, physical and chemical properties.

Regulation (EU) 2019/1009 on fertiliser products

The amended text specifies that manufacturers should ensure that the EU fertilising product is accompanied by the internet address or data carrier through which the EU declaration of conformity can be directly accessed.

For the purposes of this Regulation, products derived from animal by-products that are used solely as component materials in EU fertilising products may be made available on the market only where they originate from animal by-products or derived products that have reached an end point in the manufacturing chain in accordance with Article 5(2) of Regulation (EC) No 1069/2009.

The Commission will periodically assess whether the requirements governing the treatment of materials intended for use in fertilising products remain appropriate and, where necessary, adapt them in light of scientific and technical advances.

This review will be carried out for the first time no later than two years after the date of application of this amending Regulation.